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Last Updated: December 9, 2019

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QSYMIA Drug Profile

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When do Qsymia patents expire, and when can generic versions of Qsymia launch?

Qsymia is a drug marketed by Vivus and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-four patent family members in nineteen countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

Drug patent expirations by year for QSYMIA
Drug Prices for QSYMIA

See drug prices for QSYMIA

Generic Entry Opportunity Date for QSYMIA
Generic Entry Date for QSYMIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for QSYMIA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AstraZenecaPhase 3
Woman'sPhase 3
University of CincinnatiPhase 2

See all QSYMIA clinical trials

Recent Litigation for QSYMIA

Identify potential future generic entrants

District Court Litigation
Case NameDate
VIVUS, INC. v. TEVA PHARMACEUTICALS USA, INC.2015-04-15
VIVUS, INC. v. ACTAVIS LABORATORIES FL, INC.2014-06-12

See all QSYMIA litigation

Synonyms for QSYMIA
960078-81-3
Phentermine / topiramate
Phentermine and topiramate
Phentermine mixture with topiramate
Phentermine Topiramate
PWDLDBWXTVILPC-WGAVTJJLSA-N
Qnexa
Qsiva
Topiramate / Phentermine
VI 0521
VI-0521
Paragraph IV (Patent) Challenges for QSYMIA
Tradename Dosage Ingredient NDA Submissiondate
QSYMIA CAPSULE, EXTENDED RELEASE;ORAL phentermine hydrochloride; topiramate 022580 2013-07-18

US Patents and Regulatory Information for QSYMIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for QSYMIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012   Start Trial   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012   Start Trial   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012   Start Trial   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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